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August 10, 2010

Via Federal Express

United States Environmental Protection Agency - East

Attn: TSCA Section 8(e)

Room 6428

1201 Constitution Avenue, NW

Washington, DC 20004

329190

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Subject: Notice in Accordance with Section 8(e): Results of DECD 421

Reproduction/Developmental Toxicity Screening Test in Wistar Rats with

3-Dimethylaminopropyl oleic acid amide (CAS No, 109-28-4)

Dear Sir/Madam:

BASF Corporation is submitting results of OECD 421 Reproduction/ Developmental Toxicity

Screening Test in Wistar rats [Crl:WI(HAN)] with 3-Dimethylaminopropyl oleic acid amide (CAS No.

109-28-4), conducted by BASF SE, Ludwigshafen, Germany.

The aim of this study was to obtain information on the possible effects of 3-Dimethylaminopropyl

oleic acid amide on the integrity and performance of the male and female reproductive systems

including gonadal function, mating behavior, conception, gestation and parturition.

The study was carried out with reference to the requirements of the following guidelines:

• OECD Guidelines for Testing of Chemicals; No. 421, Reproduction/Developmental Toxicity

Screening Test (27 Jul 1995)

EPA, Health Effects Test Guidelines; OPPTS 870.3550: Reproduction/Developmental

Toxicity Screening Test (JuI2000)

The dose levels were 0; 25, 75 and 200 mg/kg body weight/day. All FO parental animals were

treated by gavage beginning on the first day of the premating period. All animals were observed

daily for any clinical signs during the study period.

After a 14-day premating period, the male and female parental animals were mated overnight in a

1:1 ratio until evidence of copulation (vaginal smear). The day on which sperm was detected was

referred to as gestation day (GD) 0 and the following day as GD 1. All parental males were

sacrificed and examined after the end of the administration period (at least 28 days). The parental

females were allowed to deliver and rear their pups until postnatal day (PND) 4. On PND 4, all pups

were sacrificed and examined.

BASF Corporation

100 Campus Drive

Florham Park, NJ 07932

Tel: (800) 526-1072

www.basfcom/usa

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BASF

The Chemical Company

United States Environmental Protection Agency - East

August 10, 2010

Page 2

The following is a summary of the most relevant results:

Test group 3: 200 mg/kg body weight/day

FO parental animals

• Clinical Examinations:

o Eyelid halfclosure in 1 male animals in the first week of treatment

o Eyelid halfclosure and piloerection temporarily in 1 female animal during gestation

and lactation.

o Decreased body weight gain in male animals in the first week of treatment (53%)

• Pathology:

o Decreased absolute terminal body weights in males (95%)

F1 pups

o Viability index decreased significantly by 6%

Test group 2: 75 mg/kg body weight/day

FO parental animals

• Clinical Examinations:

o Salivation before treatment in one male animal in treatment week 3.

• Pathology:

o Decreased absolute terminal body weights in males (96%)

F1 pups

o No test-substance related, adverse findings were observed.

Test group 1: 25 mg/kg body weight/day

FO parental animals

• Clinical Examinations:

o No test-substance related, adverse findings were observed.

• Pathology:

o No test-substance related, adverse findings were observed.

F1 pups

o No test-substance related, adverse findings were observed.

BASF Corporation

100 Campus Drive

Florham Park, NJ 07932

Tel: (800) 526-1072

www basf.com/usa
..

·BASF

The Chemical Company

United States Environmental Protection Agency - East

August 10, 2010

Page 3

BASF Corporation understands that reporting of the results from this study under TSCA 8(e) is in

accordance with EPA's policy.

If you have any questions, please call Janet Cerra at (973) 245-6693.

Sincerely,

Janet Cerra

Product Regulatory Center of Expertise

North America

1094th Letter.doc

BASF Corporation

100 CampusDrive

Florham Park,NJ 07932

Tel: (800) 526-1072

wwwbasf.com/usa
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